Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous vibro-acoustic device

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring transcutaneous vibro-acoustic therapy, anxiety

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Parkinson's Disease (Hoehn and Yahr stage 2 or higher) Individuals on or off dopaminergic therapy Present of anxiety or panic disorder Fear of falling Understanding of use and care of smart phones and devices Exclusion Criteria: Presence of significant dementia Disorders which may resemble PD, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Patients with a cardiac pacemaker History of brain surgery or placement of a deep brain stimulator Psoriasis vulgaris (or other inflammatory skin condition) on or near skin where the vibro-acoustic device and sleep tracking ring will be donned. Patients on beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for the treatment of attention deficit disorder/ADHD). Pregnancy Patients who begin cognitive behavioral therapy or a selective serotonin reuptake inhibitor (SSRI) medication for an anxiety disorder or other psychiatric disorder after the baseline clinical assessment.

Sites / Locations

Domino's FarmsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parkinson's Disease

Arm Description

Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".

Outcomes

Primary Outcome Measures

Average Nighttime Heart Rate Variability

Average heart rate variability during the night, as measured by Oura ring device (measured in s).

Paced Auditory Serial Addition Test score

A measure of cognitive function that assesses auditory information processing speed and flexibility, scored as the total number correct out of 60. Higher scores indicate better performance.

Spielberger State-Trait Anxiety Inventory score

40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety.

Hamilton Anxiety Scale score

14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety.

Hamilton Depression Scale score

17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression.

Beck Depression Inventory score

21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression.

Beck Anxiety Inventory score

21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.

Geriatric Depression Scale score

15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression.

Short Activities-specific Balance Confidence Scale score

16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence.

New Freezing of Gait Questionnaire score

9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait.

Instrumental Activities of Daily Living Scale score

8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning.

Insomnia Severity Index score

7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia.

Epworth Sleepiness Scale score

8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.

Fatigue severity Scale score

9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue.

Perceived Stress Scale score

10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress.

Short Fall Efficacy Scale International score

7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling.

Fatigue Visual Analogue Scale score (Alternate form)

Scored from 0-100, with higher score indicating greater fatigue.

Mayo Sleep Questionnaire Score on item 8

Item 8 on the Mayo Sleep Questionnaire asks the participant to rate their general level of alertness over the past 3 weeks on a scale from 0 to 10, with 0 indicating they sleep all day and 10 indicating they are fully and normally awake.

Secondary Outcome Measures

Full Information

NCT ID

NCT05962476

First Posted

June 29, 2023

Last Updated

August 10, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT05962476

Brief Title

Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Official Title

Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 9, 2023 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).

Detailed Description

The overarching goal of this study is to investigate changes in anxiety, nighttime heart rate variability, and fear of falling in people with PD before and after 3-months usage of a transcutaneous vibro-acoustic therapy device. Positive findings in this small exploratory pilot trial may support future studies of transcutaneous vibro-acoustic therapy for individuals with PD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

transcutaneous vibro-acoustic therapy, anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Parkinson's Disease

Arm Type

Experimental

Arm Description

Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".

Intervention Type

Device

Intervention Name(s)

Transcutaneous vibro-acoustic device

Other Intervention Name(s)

Apollo Neuro

Intervention Description

Wearable device which sends low-frequency sound vibrations through the skin.

Primary Outcome Measure Information:

Title

Average Nighttime Heart Rate Variability

Description

Average heart rate variability during the night, as measured by Oura ring device (measured in s).

Time Frame